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NCT Number: NCT07376460

Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment

The samples used in PRGF treatments owe their effectiveness to the handling, concentration, and preservation of their components, which explains why samples obtained with different platelet-rich plasma preparation systems may vary. At IVIRMA Group, we employ the closed system PRGF-Endoret to process these samples for StemCell Regenera samples obtained after mobilizing stem cells with granulocyte colony-stimulating factor stimulators. According to current regulations, PRP samples are considered medicinal products by AEMPS, requiring knowledge of the composition of processed samples to be administered to the patient. The study and quantification of samples used in StemCell Regenera treatments aim to understand how stem cell mobilization performed through this technique influences the characteristics of PRGF-Endoret. In this context, the present project aims to systematically analyse the proteomic profile of PRP/PRGF before and after haematopoietic stem cell mobilisation in poor-responder patients, and to evaluate its biological impact in vitro using human ovarian cell models. This approach will enable the identification of key factors involved in ovarian activation and regeneration, thereby providing a mechanistic basis for optimising regenerative therapies applied in clinical reproductive medicine. Furthermore, it will contribute scientifically relevant insights to the field of research and to patients themselves.

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Key information

Conditions

Poor Ovarian Response Ovarian Reactivation

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

The study design is based on a comparative analysis of the biological and proteomic profiles of platelet-rich plasma enriched with platelet-derived growth factors (PRP/PRGF) processed using the PRGF Endoret® kit, comparing samples obtained before (PRE) and after (POST) stem cell mobilization. The aim is to define the changes induced by the paracrine effect of bone marrow-derived stem cells (CD34⁺) mobilized into peripheral blood.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 18 and 43.
  • Patients diagnosed with poor ovarian response (POR) or low ovarian reserve according to Bolonia criteria (ESHRE).
  • Patients who are indicated for a StemCell Regenera procedure with the use of granulocyte colony-stimulating factors (Filgrastim).
  • Patients who agree to participate and sign the informed consent form.

Exclusion criteria

  • Patients over the age of 43.
  • Patients with only one ovary.
  • Patients with an autoimmune or haematological disorder.
  • Patients currently undergoing treatment with anticoagulant drugs.
  • Patients who are allergic to Filgrastim, the granulocyte colony-stimulating factor.

Treatment and study plan

Platelet Rich Plasma + BMDSCs mobilization

Combination Product

This intervention entails, in addition to routine platelet-rich plasma (PRP) isolation, prior mobilization of bone marrow derived stem cells into the peripheral blood using filgrastim, a granulocyte colony-stimulating factor. Consequently, the patient benefits both from the stem cells and their paracrine effects on the ovaries, as well as from the direct effects of intraovarian PRP instillation. Overall, this approach provides multiple benefits derived from two distinct biological sources.

Primary outcomes

  1. Biological and proteomic characterisation of the platelet rich plasma

    Time frame: From enrollment to the end of treatment (4 day treatment) at day 5

    Proteomic and biological characterisation of the platelet rich plasma before and after the peripheral blood mobilization of bone marrow derived stem cells in women with poor ovarian response who undergo the ovarian reactivation treatment StemCell Regenera

  2. In vitro functional studies with human ovarian cells

    Time frame: From enrollment to the end of treatment (4 day treatment) at day 5

    In vitro evaluation of the functional effect of PRP both before and after the stem cell mobilization on peripheral blood over human derived ovarian cells, analysing viability and proliferation parameters

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Muñoz Cantero, MD

CONTACT

[email protected]

+34 966012490

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI Alicante

Other

Collaborators

  • BTI Biotechnology Institute S.L
  • Fundación IVI

Registry information

Official study title

Biological and Proteomic Characterisation of Platelet-rich Plasma (PRP) Before and After Mobilisation of Haematopoietic Stem Cells in Peripheral Blood From Women With Low Ovarian Response (Low Responders) and in Vitro Evaluation in Human Ovarian Cell Models

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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